Guest: Dr. Keri Donaldson
Presenter: Neal Howard
Guest Bio: Dr. Keri Donaldson’s work as Medical Director and CEO of Prescient Medicine is fueled by an extensive background in the fields of pathology, genomics, and diagnostics. An active ad hoc reviewer and consultant, Dr. Donaldson has earned a reputation as an innovative member of the medical community and garnered key positions within respected institutions and national committees. He was certified as a Diplomate of both the American Board of Pathology and the National Board of Medical Examiners, and holds a BS from Pennsylvania State University, an MD from Temple University School of Medicine, and a master of science in clinical epidemiology (MSCE) from the University of Pennsylvania School of Medicine.
Segment overview: Dr. Keri J. Donaldson, Prescient Medicine’s CEO and Medical Director, discusses the role emerging medicine can play in predicting a patient’s likelihood of addiction from opioids.
Neal Howard: Hello and thank you so much for tuning into the program. I’m your host Neal Howard here on Health Professional Radio. The opioid epidemic is now triggering action from doctors and federal lawmakers. Just recently for the first time ever, the FDA requested that a drug company pull a painkiller off the market due to its potential for abuse. Now this epidemic is also raising some questions as to how we can combat the epidemic. Our guest is returning to speak with us Dr. Keri Donaldson and he’s going to talk about how genetics play a role in opioid addiction. Welcome back to Health Professional Radio Dr. Donaldson.
Dr. Keri Donaldson: Good to be back. Thanks for having us again.
N: Now, talk a little bit about the numbers of this epidemic. What constitutes an epidemic in the opioid situation here? What are the numbers telling us?
D: So Neal, unfortunately, you’re right this opioid epidemic is now declared a national emergency in the U.S. The numbers have inflated a little bit since we last talked definitely greater than 60,000, probably greater than 70,000 patients lost their lives to drug overdose in 2016. So really profound measured effect in terms of economic impact greater than 20 billion dollars spent on direct hospitalization in 2015 alone, greater than 80 billion dollars, both of those numbers are probably somewhat under counting the total cost to treat these patients and their families. It’s really, really hard to find a more measurable profound epidemic in the U.S. right now. Number one leading cause of death in adults greater than 30, less than 50, it just really, really strongly affecting unfortunately a large swath of Americans right now.
N: Now I understand that we, as the United States, we’re the world leader in opioid prescriptions. Is that a fact?
D: Absolutely. Depending upon the particular drug but definitely greater than 90%. Sometimes greater than 95% of all manufactured opioids are consumed within the US.
N: Not being a healthcare professional myself, I do understand that the CDC and many other organizations are always working to combat diseases. And oftentimes, the combat involves preventing the disease in the first place once we’ve identified an epidemic and get it under control. Is that the same way that we’re hoping that it works with this opioid epidemic or is this something totally beyond that type of solution?
D: Yes. That’s exactly what we’re trying to do. And in particular, the test that we’re talking about today, it can project, tries to identify this opioid before the patients get into the negative cycle of addiction. What do I mean by that? For 8 out of 10 patients to become addicted to illicit drugs really start with prescription opioids and the goal here is to identify the patients that have a high likelihood based upon their genetic makeup of developing dependency prior to giving that first run. So that’s exactly what you’re talking about, it’s one of the ways that you combat epidemic is identifying patients or populations at greatest risk and then really addressing for resource that need to be brought to bear to sort of stamp it out or start to snap out the feeder for this epidemic. So, you’re exactly right.
N: If I’m understanding correctly and I do believe that I am, we’re not moving away from awareness and education as a preventative measure but we’re going above and beyond that and identifying those who can be addicted or who probably will become addicted whether they’re educated or aware or not. Is that what what’s happening?
D: Yes. From what this is, is that pool that allows a more accurate assessment of risk. You’re not going to go away from awareness. You’re not going to go away from education, but what this allows practitioners, or clinicians, or prescribers or even patients, there’s a more complete understanding of their individualized list for developing dependency on these types of medication.
N: How will identifying these patients before they ever begin an opioid regimen for whatever reason or another, or being denied that regimen based on these tests? How will it impact the overall care of those who are in need of pain relief?
D: Yes. Your question right there is one of clinical utilities. And it is critical to understand that really, this is a portion of the picture but doesn’t paint the determination of how patient care occurs. Really what this particular test does, the reason we’re with you today, is we looked at genetic makeup, something that’s not really new, it goes back to 1950s or 1960s understanding that certain patients or diseases like addiction or alcoholism can run in families. We used advanced automated intelligence or machine learning to ask whether those two populations, one that has a likelihood or is dependent on opioids, there’s one that is not. If we can use genes to reliably determine whether there’s a difference for surveying that population, we can, the 97% sensitivity and 88% specificity. The performance of that test speaks to the clinical utility. Now, how is that used? The first way in which this is used and we talked about it a little already is okay, a patient is going for an elective surgery or procedure and they have an opportunity to either follow a pain regimen that would include opioid or one that has alternative therapies associated with it. Which path to choose? This just allows the practitioner or the patient to make a more informed decision which pathway they want to choose whether they’re going to include opioids as part of that prescription or that pathway, an opioid prescription or an alternative therapy. That’s the first question that it answers. Another one would be, once the patient is already addicted or in a situation where unfortunately, they’re seeking treatment for addiction, how do you go through and select the appropriate medicine? This particular test also helps with that. So that’s really what this is focused on. It’s not necessarily answering all the questions in terms of clinical utility but at least giving more guidance and a more complete picture on which pathway you should go down.
N: Seeing us how the prescription of the pharmaceutical industry that produces opioids is so closely tied and regulated by the government. But when we begin testing individuals for the likelihood of being addicted or not being addicted and the government controlling, how these opioids are prescribed or not prescribed? How much of that gets into and as you say, those who are seeking treatment for whatever reason or another, how do we navigate some of the legalities associated with identifying these people before they ever take opioids because they may not be prescription opioids that they’re susceptible to?
D: So Neal, I think that the magnitude of the problem we just discussed over the last few minutes, clearly is somewhat unique and I think that our solutions have to be somewhat unique. And I think really what we’re so excited about is that the opportunity for the government, the payers, the patients, the providers, the pharmaceutical companies to come together and be part of comprehensive solutions to address this epidemic and that’s something we’re very excited about. This is one of the new test, the new ways to deal with this, in fact it’s the first of its kind and happy to share additional information with you. We’re glad to be here again and I’m sure this is the second in a series of these talks. Additional information can be found at prescientmedicine.com, that’s PRESCIENTmedicine.com.
N: Great. And the name of the title of the study that these genetic tests are referred into the annals of clinical and laboratory science. I do believe that is that correct?
D: Yes. That’s correct. So the paper, one of the studies was published at that particular journal. There’s many others that are coming out. All those will be available on our website and happy to share or disseminate any more information if needed.
N: Always a pleasure Dr. Keri Donaldson. Thanks for coming back in and talking with us.
D: Thank you Neal. I look forward to do it again.
N: You’ve been listening to Health Professional Radio. I’m your host Neal Howard, in studio with Dr. Keri Donaldson. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm. You can subscribe to this podcast on iTunes, listen in and download it SoundCloud and be sure and visit our affiliates page when you visit our platform at hpr.fm and healthprofessionalradio.com.au.